Multi-Unit Abutment Angled, 17, 4mm Cuff 4.1/4.5mm TiLobe Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.
FDA Recall Z-0608-2018 · Posted None
Recalling FirmKeystone Dental Inc
Recall StatusTerminated
Product CodeNHA
Date Initiated2017-06-20
Date Terminated2018-04-09
Product Quantity20 units
Reason for Recall
Abutments are unable to accept the final abutment screw
Firm Action
On June 20, 2017 Keystone Dental telephoned impacted customers and advised them of the problem. On July 3rd, 2017 Keystone Dental issued notices (dated June 29, 2017) and response forms to customers via Fed Ex. Customers were encouraged to complete and return the response form attached form to confirm receipt of the replacement product and that lot 33006 can be returned to Keystone Dental. Customers with questions can call Johanna Drzyzga, Customer Relations Manager at 866-902-9272.
Root Cause
Other
Distribution Pattern
US Nationwide Distribution in the states of ND, NJ & MA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.